Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of erythema severity via erythema index with and without silicon-based formulations.
研究概览
简要总结
Delayed wound healing is considered a health problem with devastating consequences for patients, healthcare systems, and societies. Over the past 20 years, many other groups, as well as ourselves, have evaluated various alternatives to improve wound healing. Despite this, the scientific evidence demonstrating the efficacy of recently developed treatments is often limited. Stratacel® and Stratamed® are two gels approved by Swissmedic and the FDA for use in improving wound healing. To this end, the efficacy of these formulations has been visually tested by a physician or by patients. Using the most advanced medical technologies (confocal microscopy and LCOCT), this study aims to investigate the effect of these formulations on the healing of human skin. For this research, a total of 20 volunteers will be included in this study. Volunteers will have up to 7 follow-up appointments over 21 days. Each appointment will last approximately 30 minutes and will be used to perform external measurements of skin healing. All volunteers will use the same formulations (Stratacel® and Stratamed®) with the only difference between volunteers being the anatomical area of application of the formulation. This will be determined by chance. The active participation of the participant is requested for the application of the formulations on the skin twice a day during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers age ≥18 years to 50 years
- •Subjects must be willing and able to participate as required by the protocol.
- •Subjects must be willing and able to provide written informed consent.
排除标准
- •Evidence of any relevant skin or systemic disease (for example diabetes mellitus, cardiovascular disease, hypertension, chronic or acute skin disease) possibly affecting the wound healing of the test site.
- •Any skin alteration (for example tattoo or scar) on the test site.
- •Test sites with terminal hairs
- •Pregnancy or breastfeeding.
- •History of hypertrophic scars or keloid formation or a similar abnormal wound healing.
- •Intake of any drug which in the evaluation of the investigator may interfere with the interpretation of trial results or are known to cause clinically relevant interferences.
- •Body Mass Index (BMI) > 36 kg/m².
- •Have any other condition (including drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol.
结局指标
主要结局
Measurement of erythema severity via erythema index with and without silicon-based formulations.
时间窗: 21+-2 days maximum
Erythema severity is measured using the erythema index (EI). EI will be evaluated by a Mexameter by means of duplicate measurements per skin area in arbitrary units.
次要结局
- Volume of microscopic treatment zones (MTZs) and recovery time(21+-2 days maximum)
- Time needed for the scab to fall off(21+-2 days maximum)